Prospective Observational Study Research Articles

Continuous Glucose Monitoring-Derived Glycemic Phenotyping of Childhood Hypoglycemia due to Hyperinsulinism: A Year-long Prospective Nationwide Observational Study.

The glycemic characterization of congenital hyperinsulinism (HI), a rare disease causing severe hypoglycemia in childhood, is incomplete. Continuous glucose monitoring (CGM) offers deep glycemic phenotyping to understand disease burden and individualize patient care. Typically, CGM has been restricted to severe HI only, with performance being described in short-term, retrospective studies. We have described CGM-derived phenotyping in a prospective, unselected national cohort providing comprehensive baseline information for future therapeutic trials. Glycemic frequency and trends, point accuracy, and patient experiences were drawn from a prospective, nationwide, observational study of unselected patients with persistent HI using the Dexcom G6 CGM device for 12 months as an additional monitoring tool alongside standard of care self- monitoring blood glucose (SMBG). Among 45 patients with HI, mean age was six years and 53% carried a genetic diagnosis. Data confirmed higher risk of early morning (03:00-07:00 h) hypoglycemia throughout the study period and demonstrated no longitudinal reduction in hypoglycemia with CGM use. Device accuracy was suboptimal; 17 500 glucose levels paired with SMBG demonstrated mean absolute relative difference (MARD) 25% and hypoglycemia detection of 40%. Patient/parent dissatisfaction with CGM was high; 50% of patients discontinued use, citing inaccuracy and pain. However, qualitative feedback was also positive and families reported improved understanding of glycemic patterns to inform changes in behavior to reduce hypoglycemia. This comprehensive study provides unbiased insights into glycemic frequency and long-term trends among patients with HI; such data are likely to influence and inform clinical priorities and future therapeutic trials.

Chronic Kidney Disease of Unknown Etiology in Telangana: Is It Different?

Background Chronic kidney disease of unknown etiology (CKDu) is emerging as an important cause for CKD in various parts of the world, including India. This study was done to determine the risk factors and histology of CKDu in Telangana, a neighboring state of Andhra Pradesh that has CKDu hotspots. Materials and Methods This prospective observational study was done from March 2021 to November 2022 at a tertiary care center in Hyderabad. Patients were included as per the Indian CKDu definition. Sociodemographic data, examination, and investigations were obtained. Drinking water was analyzed. Patients with preserved kidney sizes underwent kidney biopsy. Patients were followed up with estimated glomerular filtration rate (eGFR) at 0.6 months and one year. Results A total of 75 patients were studied. Mean age was 41.72 +/- 13.59 years, where 68% were males. Groundwater was the drinking water source for 77.3%. In all, 40% had consumed alternate medicine and 46.6% patients had undergone kidney biopsy. The main findings were global glomerulosclerosis (>50%) in 54%, 31% had >50% interstitial fibrosis and tubular atrophy, 34.3% had periglomerular fibrosis, and 85.7% had interstitial inflammation. Hypertension was a significant risk factor for progression. Conclusion Our study results were like other Indian studies in terms of affecting younger male population, but differed from these studies as the majority of our patients came from nonagricultural backgrounds. Herbal medicine intake was a major risk factor. A vast majority of patients had chronic tubulointerstitial nephritis in biopsy at presentation, showing that most presented late.

Evaluation of abdominal expiratory muscle thickness pattern, diaphragmatic excursion, diaphragmatic thickness fraction and lung ultrasound score in critically ill patients and their association with weaning patterns: A prospective study

Abstract Introduction: Weaning of patient from ventilator and finally extubation is a challenge, especially in critical care setup. Though many parameters are available, based on which, the decision of extubation is taken but still many times, there is failure of weaning. Aim: We conducted a prospective observational study to look for diaphragm and abdominal muscle thickness, contraction, and lung ultrasound as indicator for weaning and extubation. Material and Methods: Patients of either gender aged between 20-50 years, who were on invasive mechanical ventilation for more than 48 hrs. and put on spontaneous breathing trial. A bedside ultrasound examination was performed. Abdominal expiratory muscle thickness, diaphragmatic excursion (DE), diaphragmatic thickness fraction (DTF) and lung ultrasound score (LUS) were measured. Results: 12 patients had simple weaning pattern whereas 5 patients had difficult weaning and 8 patients had prolonged weaning. The mean value of DE was 1.97 cm, DTF- 2.3 mm. The mean value of SOFA score is significant between simple, difficult, prolonged weaning (2.24, 4.56, 7.33 respectively). The DE, which is 2.52, 1.26, 1.81 in simple difficult and prolonged weaning respectively is highly significant. The mean value of LUS was 8.34 and is significant in all weaning patterns. The highest sensitivity is found for SOFA score (84.62) with AUC of 0.88. Conclusion: Evaluation of patient with diaphragm thickness fraction (mean DTF of 26%) and diaphragm excursion (2.52 cm) with mean LUS score of 4.67 opens a new dimension to predict weaning in critically ill patients who are put on spontaneous breathing trial. The sequence of thickness of abdominal expiratory muscles adds to accuracy in successful weaning. Larger muti-center trials are required to make these parameters as a standard practice for weaning patients in critical care setup.

Early Discharge Program After TAVI Based On Close Follow-up Supported by Telemonitoring Using Artificial Intelligence: the TeleTAVI Study

Abstract Introduction and objectives Evidence regarding the safety of early discharge following transcatheter aortic valve implantation (TAVI) is limited. The aim of this study was to evaluate the safety of very early (<24) and early discharge (24-48h) as compared to standard discharge (>48h), supported by the implementation of a voice-based virtual assistant using Artificial Intelligence (AI) and Natural Language Processing. Methods Single-arm prospective observational study that included consecutive patients who underwent TAVI in a tertiary hospital in 2023 and were discharged under an AI follow-up program. Primary end point was a composite of death, pacemaker implantation, readmission for heart failure, stroke, acute myocardial infarction, major vascular complications, or major bleeding, at 30-day follow-up. Results A total of 274 patients were included. 110 (40.1%) patients were discharged very early (<24h), 90 (32.9%) early (24-48h) and 74 (27.0%) were discharged after 48h. At 30-day follow-up no significant differences were found among patients discharged very early, early and those discharged after 48h for the primary endpoint (very early 9.1% vs early 11.1% vs standard 9.5%; p = 0.88). The AI platform detected complications that could be effectively addressed. The implementation of this follow-up system was simple and satisfactory for TAVI patients. Conclusions Early and very early discharge in patients undergoing TAVI, supported by close follow-up using AI, was shown to be safe. Patients with early and very early discharge had similar 30-day event rates compared to those with longer hospital stays. The AI system contributed to the early detection and resolution of complications.

Elevated systemic inflammation response index is associated with poor outcomes in minor ischemic stroke.

Patients with minor ischemic stroke (MIS) have substantial disability rates at 90 days. Our study aimed to explore the association between the systemic inflammation response index (SIRI) and 3-month functional outcomes in patients with MIS. We conducted a prospective observational study in patients with MIS [defined as a National Institutes of Health Stroke Scale (NIHSS) score of 0-3] admitted within 24 h from symptoms onset. Blood samples for the SIRI measurement were collected on admission. The primary outcome measure was poor outcomes at 90 days (defined as a modified Rankin Scale score of 2-6). Univariate and multivariate logistic analyses were performed to assess the association between the SIRI and the risk of 3-month poor outcomes. A total of 152 patients with MIS were enrolled, of which 24 cases (15.8%) had poor outcomes at 90 days. The median SIRI level was 1.27 [interquartile range (IQR), 0.77-1.92, ×10^9 /L] on admission. MIS patients with poor outcomes had higher levels of the SIRI than patients with good outcomes (poor outcomes: median, 1.93, IQR: 1.17-3.28, ×10^9 /L; good outcomes: median, 1.21, IQR: 0.71-1.80, ×10^9 /L; p = 0.003). The high SIRI level group (SIRI >1.27 × 10^9 /L) had significantly higher rates of poor outcomes at 90 days (22.4% vs. 9.2%, p = 0.026). After adjusting for age, baseline NIHSS score, prehospital delay, Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification, and other confounders in multivariate analyses, an elevated SIRI level remained independently associated with an increased risk of poor outcomes in patients with MIS [odds ratio (OR): 1.57, 95% confidence interval (CI): 1.12-2.20; p = 0.010]. Meanwhile, a high level of the SIRI (>1.27 × 10^9/L) was still an independent risk factor for 3-month poor outcomes (OR: 4.80, 95%CI: 1.51-15.29; p = 0.008) in MIS patients. Disability at 90 days was common in patients with MIS. An elevated SIRI was associated with poor outcomes in MIS patients. The SIRI might be a promising biomarker candidate that can help identify high-risk MIS patients with poor outcomes for reaching individual therapeutic decisions in clinical trials.

Comparison of Maternal and Perinatal Outcomes in Elective and Emergency Cesarean Hysterectomies: A Prospective Observational Study

Comparison of Maternal and Perinatal Outcomes in Elective and Emergency Cesarean Hysterectomies: A Prospective Observational Study

Prospective Analysis of Arteriovenous Fistula Performance in the Context of Competing Risks.

Many patients with newly created arteriovenous fistulas (AVF) may die before the AVF is needed for hemodialysis. However, formal competing risks frameworks are rarely used to report AVF patency, which may lead to biased estimates. We sought to identify the proportion of newly created AVF experiencing primary non-function and to describe long-term patency using a competing risk framework. We did a prospective observational study in 257 adults with newly created AVF in Alberta, Canada. The primary outcome was primary non-function. Secondary outcomes included loss of primary-patency, loss of assisted primary-patency, and loss of secondary functional-patency. Results were presented using icon-array plots to form the basis for future decision aids. Participants were 63.0% male with mean age 62.3 years and median follow-up of 18.5 months (range 0.02-180 months). Of 257 participants, 50 could not be assessed for function or primary non-function, usually due to death. Of the remaining 207, 102 (49.3%) had primary non-function, and function was ultimately established for 142 (68.6%). Thus, only 142 of the 257 participants (55.3%) ultimately used the AVF for hemodialysis. High rates of competing risks led to biased results from Kaplan-Meier analyses of lost patency. When accounting for competing risks, loss of primary-patency among AVF with established function was 36.6%, 65.5% and 66.2%, at 1y, 3y and 5y respectively. Only 55% of fistulas were ultimately used for hemodialysis when accounting for competing risks and primary non-function. These results and the icon-array plots may inform discussions surrounding vascular access options for patients.

Hearing Outcome after Ossiculoplasty with Teflon Ossicular Replacement Prosthesis in Modified Canal Wall Up Mastoidectomy

Background: Cholesteatoma commonly leads to damage of ossicular chain. Modified canal all up mastoidectomy is one of the commonly performed procedure for cholesteatoma worldwide. Ossiculoplasty means the operation performed to reconstruct the ossicular chain. Aim: To evaluate the hearing outcome after ossiculoplasty with teflon ossicular replacement prosthesis in modified canal wall up mastoidectomy. Methods: A prospective observational study was conducted at the Dept. of Otolaryngology-Head & Neck Surgery, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka from March 2018 to June 2020. Total 34 patients with cholesteatoma underwent modified canal wall up mastoidectomy and ossiculoplasty with teflon TORP or PORP were included in this study. All patients were followed up post-operatively upto 6 months with PTA. Results: Hearing improvement was better in ossiculoplasty with PORP. Successful results (ABG closure to within 20dB) were obtained in 35.29% & 70.58% cases in TORP & PORP group respectively after six month post-operatively. Conclusion: Ossiculoplasty with teflon ossicular replacement prosthesis gives satisfactory hearing gain. Bangladesh J Otorhinolaryngology 2024; 30(1): 24-33

What is the optimal outcome for evaluating the triage Systems? Insights from a prospective observational study

BackgroundCurrently, there is no universally accepted gold standard outcome for assessing the effectiveness of the Triage Systems. This study aimed to comprehensively evaluate and compare various outcomes utilized in triage studies. MethodsA prospective observational study was conducted at the Emergency Department (ED) of Merano Hospital from June 1 to December 31, 2023. We assessed the predictive capability of the Manchester Triage System (MTS) across multiple outcomes using areas under the receiver operating characteristic curve (AUROC), along with their corresponding 95% confidence intervals (95% CI), and frequency distributions. ResultsThe MTS demonstrated strong performance concerning the most objective outcomes, such as mortality (at 72 h: AUROC 0.914; 95 %CI: 0.815–1; at 7 days: 0.845; 95 %CI: 0.729–0.965; at 30 days: 0.794; 95 %CI: 0.706–0.881), admission to the intensive care unit (0.831; 95 %CI: 0.763–0.899), and need for life-saving interventions (0.870; 95 %CI: 0.806–0.934). Additionally, outcomes such as urgency status and clinical priority, as judged by physicians, exhibited excellent performance and optimal frequency distribution. ConclusionsThe performance of the MTS varied significantly depending on the specific outcome under evaluation. Currently, no single outcome appears superior to others, nor does any seem poised to serve as a potential gold standard for the assessment of triage systems. It is advisable for dedicated working groups to convene and reach a consensus on the most effective outcomes for evaluating the performance of MTS and other triage systems. This should be accomplished through a systematic, standardized, and transparent approach, grounded in the best available evidence.

Demographic and Clinical Characteristics in Patients with Elevated Neutrophil-Lymphocyte Ratio Undergoing Cholecystectomy

Introduction: Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to address gallbladder-related conditions, primarily gallstones and cholecystitis. This study aimed to evaluate the demographic and clinical characteristics of patients with elevated neutrophil-lymphocyte ratio undergoing cholecystectomy. Methods: This prospective observational study was conducted at the various surgical units of the inpatient Department of Surgery, Dhaka Medical College Hospital, Dhaka, from July 2018 to June 2019. Patients with cholecystitis attending in the outdoor or emergency, admitted with cholecystitis in Dhaka Medical College Hospital, Dhaka were considered as the study population. A total of 50 patients were selected as study subjects by purposive sampling technique. Statistical Package for Social Science (SPSS) version 21 for Windows was used to analyze the data. A p-value < 0.05 was considered to be significant. Result: Among 50 cholecystectomy patients, 68% were admitted as outpatients, and 32% via the emergency department. The predominant symptom was abdominal pain (92%), and the mean serum leukocyte count was significantly higher in the elevated NLR (≥3) group (13500/mm³ vs. 6200/mm³, p <0.004). Eighty percent had gallbladder calculus, with 82% diagnosed with simple cholecystitis. Most procedures (78%) were laparoscopic, and 72% did not require drains. The mean postoperative hospital stay was 4 days, longer for the elevated NLR group (median 6 days vs. 4 days, p <0.002). Complications occurred in 30% of patients, with a higher incidence in the elevated NLR group. Conclusion: The findings suggest that an elevated neutrophil-lymphocyte ratio (NLR) is linked to important clinical characteristics and outcomes, especially in older adults and males. Patients with higher NLR exhibited increased rates of laparoscopic conversion, longer operative times, and extended postoperative hospital stays. Additionally, they were more likely to need ...

Relationship between severe radiodermatitis and skin barrier functions in patients with head and neck cancer: A prospective observational study

ObjectiveSevere radiodermatitis with erosion is a painful condition that affects quality of life; therefore, developing methods for its prevention is an urgent issue. Therefore, this study aimed to determine the morphological characteristics of the development and healing processes of severe radiodermatitis in patients with head and neck cancer and to explore the association between skin barrier function and development of severe radiodermatitis. MethodsIn this prospective observational study, the cervical regions of patients with head and neck cancer who underwent radiotherapy at a university hospital from October 2022 to March 2023 were photographed, and morphological characteristics of the development and healing process of severe radiodermatitis were extracted using the qualitative sketch method. Skin barrier function, including skin microbiota and dermal echogenicity, was investigated before initiating radiotherapy, and its relationship with radiodermatitis was examined using the Mann–Whitney U test or Fisher's exact probability test. ResultsNine patients were followed for a median of 61 (range 55–87) days with a total of 88 observations. The morphological characteristics of severe radiodermatitis were “localized erosion–epithelialization” and “widespread erosion–crusting,” and compared to non-severe radiodermatitis, with low levels of Staphylococcus aureus (P ​= ​0.024), Staphylococcus hominis (P ​= ​0.024), and reduced dermal echogenicity (P ​= ​0.036). Furthermore, the “widespread erosion–crusting” was associated with a subepidermal low echogenic band. ConclusionsTo prevent severe radiodermatitis, in addition to moisturizing the irradiated area and protecting it from mechanical irritation, improving skin barrier function before radiotherapy initiation may be effective.

Long-term outcomes following the resection of screen-detected right-sided colon cancer.

The relative outcomes following the resection of screen-detected right-sided colon cancer compared to symptomatic cases are unknown. In this study, short and long-term outcomes after right-sided colectomy in screen-detected colon cancer are compared with symptomatic cases, both emergency and elective. A prospective observational cohort study of patients, including both screen-detected and symptomatic patients (elective and emergency resections), undergoing right-sided colectomy for colon cancer (2010-2020) in a tertiary care unit was conducted. Each patient was followed up for long-term recurrence and survival. A total of 909 patients (median age, 70; IQR, 58-82; male, 52%) were included (151 patients (16.6%) screen-detected; 598 (65.8%) elective and 160 (17.6%) emergency). Screen-detected patients were more likely to haveT1 or T2 lesions compared to elective and emergency groups (T1: 14.6% vs. 3.8% vs. 0.6% p<0.001; T2: 16.6% vs. 8.9% vs. 3.1% p<0.001), but were less likely to have T3 or T4 lesions (p<0.001), respectively. Rates of N0 were higher in the screen-detected group (68.9% vs. 63.5% vs. 41.9%, respectively; p<0.001). 98% of the screen-detected group achieved R0 resection compared to 93.3% of elective and 79.4% of emergency patients (p<0.001). At 5-years following resection, overall survival for the screen-detected, elective, and emergency groups were 85.4%, 75.4%, and 53.1%, respectively (p<0.001). Recurrence at 5-year post-resection were 8%, 15.1%, and 22.5% for the screen-detected, elective, and emergency groups, respectively (p<0.001). When considering right-sided colon cancer alone, screen-detected cancers have a lower long-term recurrence rate, lower rates of postoperative complication, and superior survival compared to symptomatic groups following resection.

Prevalence and management of anemia and impact of treatment burden on health-related quality of life in chronic kidney disease and dialysis patients.

Anemia management in chronic kidney disease (CKD) is a significant challenge for healthcare professionals worldwide. The extensive management of CKD and its complications is directly linked with a substantial treatment burden, which impacts quality of life (QoL). This study aimed to assess the prevalence and management of anemia and to evaluate the treatment burden and its impact on the QoL of CKD and dialysis patients in Pakistan. A multicenter prospective observational study was conducted in three hospitals. A total of 170 patients were enrolled, with 156 available for follow-up after six months. Their prior consent was obtained. Each participant was interviewed in person and received a data collection form. At baseline, the prevalence of anemia among CKD (stage 3-5) and dialysis patients was 78.7% and 94.7%, respectively. Patients on dialysis used more erythropoietin stimulating agents (ESAs), with 38.6% at baseline and 40.8% by month six, compared to non-dialysis CKD patients. Oral iron was used by 6.2% of stage 3, 25% of stage 4, 20% of stage 5 patients, and 6.6% of dialysis patients at baseline. At the six-month follow-up, 42.8% of CKD and 33.8% of dialysis patients achieved the target hemoglobin level. Dialysis patients had a higher treatment burden compared to CKD at baseline (77.4±10.6 vs 59.3±13.3) and at six-month visit (79.3±11.1 vs 59.1±14.5). The multiple regression analysis showed that treatment burden had a significant association with age, disease duration, and comorbidity at baseline. There was a significant negative correlation between overall treatment burden and QoL, indicating that QoL decreases as treatment burden increases. Anemia was prevalent, and its management was suboptimal in this study. The overall treatment burden score was high in dialysis patients, negatively affecting the QoL.

Use of Multiparametric and Biparametric Magnetic Resonance Imaging in Bladder Cancer Staging: Prospective Observational Study and Analysis of Radiologist Learning Curve.

Background: Nowadays, thanks to the introduction of the VI-RADS scoring system, mpMRI has shown promising results in pre-TURBT assessment of muscular invasiveness of BCa, even if its application in everyday practice is still limited. This might be due to a lack in the literature about the learning curve of radiologists and about the characteristics of the exam. With the aim to reduce scan time and patient discomfort while maintaining diagnostic accuracy, bpMRI has been introduced as a possible alternative to mpMRI in this group of patients. This study reports a single-center experience using mpMRI and the VI-RADS scoring system to differentiate NMIBC from MIBC. The primary aim of the study is to assess diagnostic accuracy of mpMRI using the VI-RADS scoring system. The secondary aim is to evaluate the learning curve of an experienced mpMRI radiologist. Additionally, we perform a retrospective assessment of the same group of patients evaluating only DWIs and T2-weighted images, as they underwent bpMRI, to compare the performance of mpMRI and bpMRI. Materials and Methods: From 11/2021 to 11/2023, patients with suspected newly diagnosed BCa were enrolled in this prospective study. All patients underwent mpMRI prior to TURBT in a highly specialized radiology center for MRI. According to VI-RADS, a cutoff of ≥3 was assumed to define MIBC. Histological TURBT reports were compared with preoperative VI-RADS scores to assess the accuracy of mpMRI in discriminating between NMIBC and MIBC. Furthermore, to assess the learning curve of the reading radiologist we analyzed the rate of patients correctly classified as MIBC at MRI. Finally, we evaluated the performance of a hypothetic biparametric MRI in classifying our cohort according to VI-RADS score and compared it with mpMRI performance by using DeLong's test. Data analysis was performed using Jamovi software v.2.3 and R software v.4.2.1. Results: A total of 133 patients were enrolled. mpMRI showed sensitivity and specificity of 86% (95% confidence interval [CI]: 64-97) and 95% (95% CI: 89-98), respectively. The learning curve analysis of the reading radiologist showed that the rate of patients correctly classified as MIBC rapidly increases reaching its plateau after 40 cases. The hypothetic bpMRI showed a sensitivity of 76% (95% CI: 53-92) and a specificity of 93% (95% CI: 86-97), with no significant difference with mpMRI performance (p = 0.10). Conclusions: Our study confirms the effectiveness of MRI, particularly with the VI-RADS scoring system, in differentiating NMIBC from MIBC. The learning curve analysis underscores the importance of radiologist training in optimizing diagnostic accuracy. Future research should focus on enhancing the sensitivity of bpMRI and further validating these findings in larger and multicentric studies.

Celiac Disease and Inflammatory Cardiomyopathies: Exploring the Heart-Gut Axis.

Background: Celiac disease (CD) is associated with an increased risk of cardiovascular (CV) events, especially inflammatory heart diseases. We aimed to gather evidence on the association between CD and inflammatory CV diseases, including pericarditis and myocarditis, and the underlying pathophysiological mechanisms. Methods: The PubMed, Scopus, and Google Scholar databases were searched for studies assessing the prevalence and the long-term outcomes of patients with CD and inflammatory CV diseases. Result: Ten studies (nine case series/reports and one prospective observational study) covering a total of 22 patients, including 9 women (41%) and 13 men (59%), were evaluated. The median age was 23 (IQR, 12-41) years. A total of 6 patients had recurrent pericarditis, while 16 patients had celiac-related myocarditis (11 patients presented with heart failure and 5 with arrhythmia). A strict gluten-free diet (GFD) alone was effective in 87.5% of cases (4/6 for pericarditis and 10/16 for myocarditis). All patients with pericarditis achieved complete resolution of symptoms. Conversely, heart function was restored in 81% of patients with myocarditis. Only one patient died. Conclusions: Myocarditis and/or pericarditis, especially if recurrent, may complicate CD in pediatric and adult subjects due to an autoimmune reaction involving the pericardium/myocardium and the small intestine.

Placental lesions in birth asphyxia and hypoxic ischemic syndrome.

Birth asphyxia is a severe condition that includes a number of potential pathways of occurrence both in utero and during childbirth. The present study aimed to identify and describe specific macroscopic and microscopic placental injuries in birth asphyxia to serve as an effective tool to stratify the potential further evolution of a newborn, as hypoxic ischemic encephalopathy can be responsible for neonatal death or severe neurological sequelae further, compromising the quality of life of the affected individual. For this purpose, an observational prospective study was conducted over a period of 3 years. A total of 62 patients diagnosed with birth asphyxia, who had a placental histopathological examination performed were enrolled in the study. The control group consisted of 69 term newborns that required neonatal intensive care for at least 3 days, in the same time period, for any other reason and that also had available placental examinations. In the present study, placental histopathological lesions identified in birth asphyxia have been classified according to the Amsterdam Criteria. Data gathered from both groups were analyzed by applying specific statistical tests for each type of variable and hypothesis. Thus, umbilical cord abnormalities were associated with hypoxic ischemic encephalopathy in a statistically significant manner when comparing the birth asphyxia group of newborns with the control group. In addition, a high statistical level of significance was identified for microscopical lesions, such as maternal and fetal vascular malperfusion and the occurrence of hypoxic ischemic syndrome when comparing the two groups (P=0.01). The macroscopic and microscopic placental examination can provide critical information for the evolution of the disease in selected newborns according to the identified lesions.

Accurately predicting mood episodes in mood disorder patients using wearable sleep and circadian rhythm features

Wearable devices enable passive collection of sleep, heart rate, and step-count data, offering potential for mood episode prediction in mood disorder patients. However, current models often require various data types, limiting real-world application. Here, we develop models that predict future episodes using only sleep-wake data, easily gathered through smartphones and wearables when trained on an individual’s sleep-wake history and past mood episodes. Using mathematical modeling to longitudinal data from 168 patients (587 days average clinical follow-up, 267 days wearable data), we derived 36 sleep and circadian rhythm features. These features enabled accurate next-day predictions for depressive, manic, and hypomanic episodes (AUCs: 0.80, 0.98, 0.95). Notably, daily circadian phase shifts were the most significant predictors: delays linked to depressive episodes, advances to manic episodes. This prospective observational cohort study (ClinicalTrials.gov: NCT03088657, 2017-3-23) shows sleep-wake data, combined with prior mood episode history, can effectively predict mood episodes, enhancing mood disorder management.

Circulating cell‐free DNA in liver transplantation: A pre‐ and post‐transplant biomarker of graft dysfunction

AbstractBackgroundLiver transplantation (LT) is still limited by organ shortage and post‐transplant monitoring issues. While machine perfusion techniques allow for improving organ preservation, biomarkers like donor‐derived cell‐free DNA (dd‐cfDNA) and mitochondrial cfDNA (mt‐cfDNA) may provide insights into graft injury and viability pre‐ and post‐LT.MethodsA prospective observational cohort study was conducted on LT recipients (n = 45) to evaluate dd‐cfDNA as a biomarker of graft dysfunction during the first 6 months after LT. Dd‐cfDNA was quantified on blood samples collected pre‐LT and post‐LT using droplet digital PCR. In livers undergoing dual hypothermic oxygenated machine perfusion (D‐HOPE), total cfDNA and mt‐cfDNA levels were measured on perfusate samples collected at 30‐min intervals. Correlations with graft function and clinical outcomes were assessed.ResultsDd‐cfDNA levels peaked post‐LT and correlated with transaminase levels and histological injury severity. The longitudinal assessment showed that postoperative complications and rejection were associated with an increase in dd‐cfDNA levels. Mt‐cfDNA levels in D‐HOPE perfusate correlated with graft function parameters post‐LT and were higher in patients with early allograft dysfunction and severe complications.ConclusionsThis study confirms dd‐cfDNA as a marker of graft injury after LT and suggests that perfusate mt‐cfDNA levels during D‐HOPE correlate with graft function and post‐transplant clinical outcome. Integration of these tests into clinical practice may improve transplant management and viability assessment during hypothermic perfusion.

Myocardial deformation in children post cardiac surgery, a cross-sectional prospective study

BackgroundMyocardial deformation by speckle tracking echocardiography provides valuable information on the left ventricular function. The study aims to assess myocardial deformation in terms of left ventricular strain as an indicator of myocardial function in children after cardiac surgery at outpatient follow-up visits.MethodsThe study design was a prospective observational cross-sectional study that included pediatric patients after biventricular cardiac surgery during the postoperative follow-up visits in the outpatient department. In addition to conventional echocardiographic examination, two-dimensional speckle tracking echocardiography was done to evaluate myocardial deformation in terms of left ventricular strain. Echocardiographic measurements were done offline and were compared to published reference normal values for age. Study subjects were divided according to age at follow-up into four groups (1 month–1 year, 1–2 years, 2–5 years, and 5–11 years).ResultsOver ten months, 100 patients (64 males and 36 females) were included in the study. The median age was 30.8 months (IQR 12.8–65.3 months), the median weight was 11.7 kg (IQR 8–17 kg) and the median duration after surgery was 7.3 months (IQR 3.2–30.8 months). Longitudinal strain values were significantly (p < 0.001) lower than reference values for different age groups. Global circumferential strain showed no significant difference from the reference values. The duration after surgery had a statistically significant effect on longitudinal strain values, with improvement of the strain values with increasing intervals after surgery.ConclusionUsing myocardial deformation method to evaluate cardiac function may detect underlying cardiac function abnormalities even with normal traditional functional parameters, which could have implications for patient management and follow-up.

Unpredictable Aortic Behavior in Identifying Risk Factors for Reintervention: A Prospective Cohort Study.

Although advancements in the management of thoracic aortic disease have led to a reduction in acute mortality, individuals requiring postoperative reintervention experience substantially worse long-term clinical outcomes and increased mortality. We aimed to identify the risk factors for postoperative reintervention in this high-risk population. This prospective observational cohort study included patients who survived endovascular or open surgical treatment for thoracic aortic disease between January 2009 and June 2020. We excluded those with inflammatory or traumatic thoracic aortic diseases. The risk factors were identified using multivariate logistic regression and Cox proportional hazards regression models. The study included 95 genetically tested patients aged 54.13 ± 12.13 years, comprising 67 men (70.53%) and 28 women (29.47%). Primary open surgery was performed in 74.7% and endovascular repair in 25.3% of the patients. Of these, 35.8% required one or more reinterventions at the time of follow-up (3 ± 2.5 years, mean ± standard deviation). The reintervention rate was higher in the endovascular repair group than in the open repair group. Among the potential risk factors, only residual aortic dissection emerged as an independent predictor of reintervention (odds ratio: 3.29, 95% confidence interval: 1.25-8.64). Reintervention after primary thoracic aortic repair remains a significant clinical issue, even in high-volume tertiary centers. Close follow-up and personalized care at aortic centers are imperative. In our cohort of patients with thoracic aortic disease undergoing open or endovascular surgery, postoperative residual dissection was independently associated with the necessity of reintervention, emphasizing the importance of intensified clinical monitoring in these patients.